Orelabrutinib in the Treatment of HP-positive Gastric MALT Lymphoma

Fudan University

Status and phase: Enrolling; Phase 2

Conditions: Helicobacter Pylori Infection; MALT Lymphoma of Stomach

Treatments: Drug: Triple therapy for eradication of Helicobacter Pylori; Drug: Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib

Study type: Interventional

Funder types: Other

Identifiers

NCT06228963

iNHL-02

Details and patient eligibility

About

Describe the efficacy and safety of Orelabrutinib in the treatment of HP-positive gastric MALT lymphoma

Full description

This multicenter, open-label, randomized controlled trial is trying to evaluate the efficacy and safety of Orelabrutinib in the first-line treatment of HP-positive gastric MALT lymphoma

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18 years old
• Histologically confirmed gastric mucosa-associated lymphoid tissue (MALT) lymphoma;
• Current infection with Helicobacter pylori (Hp): Diagnosis can be made if any of the following criteria are met: a) Positive result in at least one of the following: RUT (rapid urease test), histological staining, or bacterial culture of gastric mucosal tissue; b) Positive result in 13C or 14C-UBT (urea breath test); c) Positive result in HpSA detection. A positive result in serum Hp antibody test indicates past infection, and patients who have never been treated can be considered as having current infection.
• ECOG (Eastern Cooperative Oncology Group) performance status 0-2.
• Lugano staging I-II1.
• Signed informed consent form.
• Evaluable lesions present.

Exclusion criteria

• Negative for Helicobacter pylori (HP);
• History of other tumors, except for cured cervical cancer or basal cell carcinoma of the skin;
• Patients with active HIV and syphilis infections;
• Pregnant or lactating women;
• Patients with severe active infections;
• Patients with multiple factors affecting oral medication (such as dysphagia, nausea, vomiting, chronic diarrhea, and intestinal obstruction);
• Other comorbidities or conditions that may prevent patients from completing the clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Experimental group

Experimental group

Description:

Triple therapy for eradication of Helicobacter Pylori+Orelabrutinib

Treatment:

Drug: Triple therapy for eradication of Helicobacter Pylori and Orelabrutinib

Control group

Active Comparator group

Description:

Triple therapy for eradication of Helicobacter Pylori

Treatment:

Drug: Triple therapy for eradication of Helicobacter Pylori